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Sponsors and Collaborators: |
Rheumazentrum Ruhrgebiet Centocor BV Trial Coordination Center, 9713 GZ Groningen PPD Development, CB1 6 GQ Cambridge |
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Information provided by: | Rheumazentrum Ruhrgebiet |
ClinicalTrials.gov Identifier: | NCT00237419 |
Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active AS on a short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on a long-term basis over 4 years is safe and efficient and can prevent radiographic progression over a long period of time. Further we want to learn about the outcome after discontinuation of anti-TNF-alpha therapy.
Condition | Intervention |
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Ankylosing Spondylitis |
Drug: infliximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Extension, Investigator Initiated Trial to Examine Radiographic Progression , Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis. EASIC (European Ankylosing Spondylitis Infliximab Cohort) |
Estimated Enrollment: | 149 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Chronic inflammation of entheses leads to new bone formation, syndesmophytes and ankylosis of joints, primarily in the axial skeleton. This leads to a dramatic loss of range of motion and to disability. The disease may also have nonskeletal manifestations including uveitis, carditis, pulmonary fibrosis and cardiac conduction abnormalities.
Current therapy for AS is mainly with NSAIDs and physiotherapy which are often insufficient. Clinical outcome with conventional therapies has not been good, with 50-70% of patients progressing to fusion of the spine by 10 to 15 years. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active ankylosing spondylitis on a short- and a long-term basis over 2 years.
There is limited data available on the efficacy and safety of long-term anti-TNF therapy for 3 and more years, the outcome after discontinuation of anti-TNF therapy and the effect of anti-TNF therapy on radiographic progression over a long period of time.
The ASSERT trial was a 2 year international randomized placebo controlled trial to evaluate the efficacy and safety ot treatment with infliximab in patients with active and severe AS. The EASIC trial is initiated to follow the European participants of the ASSERT trial for at least an additional 2 years of treatment combined with systematic data collection.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jürgen Braun, Prof. Dr. | +49 (0) 2325 592131 | j.braun@rheumazentrum-ruhrgebiet.de |
Contact: Frank Heldmann, Dr. med. | + 49 (0) 2325 592138 | heldmann@rheumazentrum-ruhrgebiet.de |
Belgium | |
University Hospital Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Kurt de Vlam, Dr. +32 (0) 16 332 211 kurt.devlam@pi.be | |
Contact: Rene Westhovens, Prof. Dr. +32 (0) 16 344 792 rene.westhovens@uz.kuleuven.ac.be | |
Principal Investigator: Rene Westhovens, Prof.Dr. | |
Limburg University Centre | Recruiting |
Diepenbeek, Belgium | |
Contact: Piet Geusens, Prof. Dr. +32 (0) 89 362977 piet.geusens@ping.be | |
Principal Investigator: Piet Geusens, Prof. Dr. | |
Erasme University Hospital | Recruiting |
Brussels, Belgium | |
Contact: Serge Steinfeld, Prof. Dr. +32 (0) 25 556 745 ssteinfe@ulb.ac.be | |
Principal Investigator: Serge Steinfeld, Prof.Dr. | |
Universitair Ziekenhuis, Afdeling Rheumatologie | Recruiting |
Gent, Belgium, 9000 | |
Contact: Filip Van den Bosch, Dr. filip.vandenbosch@skynet.be | |
Principal Investigator: Filip van den Bosch, Dr. | |
Finland | |
University Central Hospital, Division of Rheumatology | Recruiting |
Helsinki, Finland, 00029HYKS | |
Contact: Marjatta Leirisalo-Repo, Prof Marjatta.Leirisalo-Repo@hus.fi | |
Principal Investigator: Marjatta Leirisalo-Repo, Prof. Dr. | |
France | |
Groupe Hopitalier Cochin | Recruiting |
Paris, France | |
Contact: Maxime Breban, Prof.Dr. +33 (0) 1 49095672 maxime.breban@cch.ap-hop-paris.fr | |
Principal Investigator: Maxime Breban, Prof.Dr. | |
Universitat R. Descartes, Hopital Cochin | Recruiting |
Paris, France | |
Contact: Sami Kolta, Dr. +33 (0) 1 5841 2584 sami.kolta@cch.ap-hop-paris.fr | |
Contact: Maxime Dougados, Prof.Dr. +33 (0) 1 5841 2562 m-doug@cch.ap-hop-paris.fr | |
Principal Investigator: Maxime Dougados, Prof.Dr. | |
Germany | |
Charite Mitte | Recruiting |
Berlin, Germany, 10117 | |
Contact: Gerd Burmester, Prof. Dr. +49 (0) 30 45051 3082 gerd.burmester@charite.de | |
Contact: Bettina Marsmann +49 (0) 30 45051 3025 bettina.marsmann@charite.de | |
Principal Investigator: Gerd Burmester, Prof. Dr. | |
Charite Klinikum Steglitz | Recruiting |
Berlin, Germany, 12200 | |
Contact: Henning Brandt, Dr. +49 (0) 30 8445 4414 henning.brandt@charite.de | |
Principal Investigator: Joachim Sieper, Prof.Dr. | |
Ludwigs-Maximilian-Universität | Recruiting |
München, Germany, 80336 | |
Contact: Christine Strasser +49 (0) 89 51603511 Christine.Strasser@med.uni-muenchen.de | |
Principal Investigator: Stefan Schewe, Prof.Dr. | |
Sub-Investigator: Matthias Gruenke, Dr. med. | |
Rheumazentrum Ruhrgebiet | Recruiting |
Herne, Germany, 44652 | |
Contact: Frank Heldmann, Dr. +49 (0) 2325 592138 heldmann@rheumazentrum-ruhrgebiet.de | |
Contact: Jürgen Braun, Prof. Dr. +49 (0) 2325 592 131 j.braun@rheumazentrum-ruhrgebiet.de | |
Principal Investigator: Jürgen Braun, Prof. Dr. | |
Netherlands | |
University Hospital Maastricht | Recruiting |
Maastricht, Netherlands, 6202 AZ | |
Contact: Annelies Boonen + 31 (0) 43 388 42 33 aboo@sint.azm.nl | |
Contact: Robert Landewe, Prof. Dr. +31 (0) 43 387 7010 Rlan@sint.azm.nl | |
Principal Investigator: Robert Landewe, Prof.Dr. | |
Academic Ziekenhuis | Recruiting |
Amsterdam, Netherlands, 1007MB | |
Contact: I.E van der Horst-Bruinsma, Dr. +31 (0) 20 4443432 IE.vanderHorst@vumc.nl | |
Contact: B.A.C Dijkmans, Prof.Dr. +31 (0) 20 4443432 bac.dijkmans@vumc.nl | |
Principal Investigator: B.A.C Dijkmans, Prof. Dr. | |
United Kingdom | |
University of Leeds | Recruiting |
Leeds, United Kingdom, LS2 9N2 | |
Contact: Mrs. Keen, Dr. +44 (0) 113 392 24848 | |
Contact: Paul Emery, Prof.Dr. +44 (0) 113 392 5068 p.emery@leeds.ac.uk | |
Principal Investigator: Paul Emery, Prof.Dr. | |
University of Cambridge/ Clin Med | Recruiting |
Cambridge, United Kingdom, CB2 QQ | |
Contact: Hill Gaston, Prof. Dr. +44 (0) 1233 330161 jshg2@medschl.cam.ac.uk | |
Principal Investigator: Hill Gaston, Prof.Dr. |
Principal Investigator: | Jürgen Braun, Prof. Dr. | Rheumazentrum Ruhrgebiet |
Responsible Party: | Rheumazentrum Ruhrgebiet ( Prof. Dr. Jürgen Braun ) |
Study ID Numbers: | EASIC 30505 |
Study First Received: | October 10, 2005 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00237419 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Ankylosing spondylitis Long-term therapy with infliximab Radiographic progression |
Spinal Diseases Infliximab Joint Diseases Spondylarthropathy Disease Progression Bone Diseases Musculoskeletal Diseases |
Arthritis Spondylitis, Ankylosing Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |
Anti-Inflammatory Agents Disease Attributes Pathologic Processes Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Infection Dermatologic Agents Pharmacologic Actions Bone Diseases, Infectious |